SAFINAMIDE MESYLATE - Generic Drug Details

What are the generic sources for safinamide mesylate and what is the scope of patent protection?

Safinamide mesylate is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, MSN, Prinston Inc, Zenara, and Mdd Us, and is included in five NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Safinamide mesylate has ninety-seven patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for SAFINAMIDE MESYLATE

International Patents:	97
US Patents:	3
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Patent Applications:	204
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SAFINAMIDE MESYLATE
What excipients (inactive ingredients) are in SAFINAMIDE MESYLATE?	SAFINAMIDE MESYLATE excipients list
DailyMed Link:	SAFINAMIDE MESYLATE at DailyMed

Pharmacology for SAFINAMIDE MESYLATE

Drug Class	Monoamine Oxidase Type B Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Monoamine Oxidase-B Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SAFINAMIDE MESYLATE

N04BD	Monoamine oxidase B inhibitors
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for SAFINAMIDE MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Prinston Inc	SAFINAMIDE MESYLATE	safinamide mesylate	TABLET;ORAL	215739-002	Apr 25, 2024	AB	RX	No	No
Aurobindo Pharma	SAFINAMIDE MESYLATE	safinamide mesylate	TABLET;ORAL	215902-002	Jun 14, 2023		DISCN	No	No
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017	AB	RX	Yes	No	8,076,515		Y	Y
Msn	SAFINAMIDE MESYLATE	safinamide mesylate	TABLET;ORAL	215978-001	Dec 31, 2024	AB	RX	No	No

International Patents for SAFINAMIDE MESYLATE

Country	Patent Number	Title	Estimated Expiration
Cyprus	1115286
Poland	2029524
Spain	2454272
China	1771030	Methods for treatment of parkinson's disease

Supplementary Protection Certificates for SAFINAMIDE MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	CR 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
1613296	92782	Luxembourg		PRODUCT NAME: SAFINAMIDE A UTILISER EN COMBINAISON AVEC LEVODOPA/PDI, ET EVENTUELLEMENT AVEC D'AUTRES MEDICAMENTS PD , POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON; FIRST REGISTRATION DATE: 20150224
1613296	C20150033 00258	Estonia		PRODUCT NAME: SAFINAMIID;REG NO/DATE: EU/1/14/984 26.02.2015
1613296	300752	Netherlands		PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224

Market Dynamics and Financial Trajectory for SAFINAMIDE MESYLATE

Last updated: July 27, 2025

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Introduction

Safinamide mesylate is a highly selective, reversible monoamine oxidase B (MAO-B) inhibitor primarily developed for the management of Parkinson’s disease (PD). Building on its dual mechanism—combining MAO-B inhibition with modulation of glutamate release—safinamide has carved a niche within the therapeutic landscape, particularly as an adjunct to levodopa therapy. Its unique profile presents both opportunities and challenges, shaping its market dynamics and forecasted financial trajectory within the neurodegenerative disease sector.

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Pharmacological Profile and Clinical Credentials

Safinamide mesylate’s dual mechanism of action enhances its appeal. Unlike traditional MAO-B inhibitors such as selegiline and rasagiline, safinamide also modulates glutamate release, addressing both dopaminergic and non-dopaminergic pathways involved in PD pathophysiology. Approved by the FDA in 2017 and by the European Medicines Agency (EMA) in 2015, safinamide is marketed under the brand name Xadago® (in the US and select markets).

Its clinical efficacy in improving motor fluctuations—particularly "wearing-off" phenomena—has been demonstrated in multiple Phase III trials. The drug’s tolerability profile, with fewer dietary restrictions and drug interactions compared to older MAO-B inhibitors, further bolsters its market potential.

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Market Drivers

1. Rising Prevalence of Parkinson’s Disease

The global PD prevalence exceeded 6.1 million in 2016, projected to reach approximately 12 million by 2040, driven by aging populations and improved diagnostic criteria [1]. This demographic shift escalates demand for symptomatic treatments like safinamide.

2. Expanding Treatment Paradigms

Current PD therapies focus on symptom management, with an emphasis on personalized regimens. Safinamide’s dual mechanism offers a differentiated approach—potentially improving quality of life and reducing motor fluctuations seen with levodopa monotherapy.

3. Regulatory Approvals and Expanded Indications

While initially approved for adjunctive therapy in patients experiencing motor fluctuations, ongoing trials evaluate safinamide as monotherapy and across broader neurodegenerative conditions. Such approvals could broaden its market penetration.

4. Growing Patient and Physician Acceptance

As clinicians recognize safinamide’s safety profile and efficacy, prescriptions are expected to increase. Additionally, its once-daily oral dosing simplifies adherence, further supporting market growth.

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Market Challenges

1. Competition from Established MAO-B Inhibitors

Rasagiline (A(z)ilect®) and selegiline remain core treatments. Their longstanding clinical histories and penetration present initial barriers for safinamide’s exponential market expansion.

2. Patent and Exclusivity Concerns

Safinamide's patent protection—originally granted in multiple markets—faces expiration timelines. Patent cliffs threaten generic competition, affecting pricing strategies and profit margins.

3. Market Access and Reimbursement

Price sensitivity in healthcare systems, especially in cost-conscious markets like the U.S. and Europe, may constrain sales unless safinamide demonstrates clear clinical advantages or cost-effectiveness.

4. Limited Data in Broader Indications

While promising, safinamide’s approval is limited primarily to PD adjunct therapy. Expansion into other neurodegenerative diseases requires substantial clinical data, delaying diversification.

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Financial Trajectory and Forecasts

Current Market Status

As of 2023, safinamide’s global sales are estimated at approximately $300–$400 million annually, with the bulk originating from the U.S., Europe, and parts of Asia. The drug’s revenue has experienced consistent growth, averaging around 15% annually since its launch, driven by increased prescription volume and expanding insurance coverage.

Projected Growth Trends

Industry analysts project the safinamide market to reach $700–$800 million by 2030, with a compound annual growth rate (CAGR) of approximately 8–10%. Factors influencing this trajectory include:

• Increased adoption in clinical guidelines for Parkinson’s management.
• Expansion into emerging markets with rising PD prevalence.
• Potential new indications, especially if ongoing trials demonstrate efficacy in other neurodegenerative conditions.

Market Penetration Strategies

Pharmaceutical companies are investing in post-marketing studies, physician education, and patient advocacy to accelerate prescription rates. Additionally, partnerships with regional healthcare providers facilitate access in markets with stringent reimbursement processes.

Impact of Patent Expirations

Patent expiry in key territories from 2024 onward may introduce generic alternatives, exerting downward pressure on prices and sales unless brand differentiation persists. Strategies such as formulation enhancements or combination therapies could mitigate this threat.

Cost-Effectiveness and Pricing Dynamics

Market success hinges on demonstrating cost-effectiveness. Real-world evidence highlighting improved patient outcomes and reduced healthcare utilization will bolster reimbursement prospects, thereby stabilizing revenue streams.

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Regulatory and Market Expansion Outlook

Global Regulatory Environment

Most mature markets have already approved safinamide. Continued approvals for additional indications or expanded dosing regimens could catalyze sales. Regulatory bodies are increasingly emphasizing real-world evidence, influencing post-approval market access.

Pipeline and Future Prospects

Ongoing studies exploring safinamide’s role in conditions like epilepsy, depression, and other neurodegenerative disorders could lead to off-label or label expansions, augmenting revenue.

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Conclusion

Safinamide mesylate stands at a pivotal point in its market journey. Its distinct pharmacological profile, aligned with rising Parkinson’s disease prevalence, positions it favorably for continued growth. However, competition, patent expirations, and reimbursement hurdles necessitate strategic approaches—focusing on clinical differentiation, expanding indications, and geographic penetration—to maximize financial returns. The drug's market trajectory appears optimistic, with potential to become a cornerstone adjunct therapy in PD management and possibly beyond.

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Key Takeaways

• The global Parkinson’s disease burden fuels ongoing demand for safinamide, underpinning its market growth.
• Safinamide’s dual mechanism and safety profile confer a competitive advantage over older MAO-B inhibitors.
• Competitive landscape and patent expiration are critical factors influencing future sales and profitability.
• Expansion into new indications and markets, coupled with strategic partnerships, will be pivotal for sustained revenue escalation.
• Demonstrating cost-effectiveness and securing reimbursement approvals remain essential for broader market access.

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FAQs

1. What distinguishes safinamide mesylate from other MAO-B inhibitors?
Safinamide uniquely combines selective MAO-B inhibition with modulation of glutamate release, offering a dual mechanism that may provide superior control over motor fluctuations and neuroprotective effects compared to older agents like rasagiline or selegiline.

2. When is safinamide expected to face generic competition?
Patent protections in major markets are set to expire around 2024–2025. Post-expiry, generic formulations are anticipated, potentially impacting brand revenues unless the branded product sustains its clinical and market differentiation.

3. Can safinamide be used as a monotherapy?
Currently, safinamide approval is limited to adjunctive use with levodopa in managing motor fluctuations. Clinical trials investigating monotherapy are ongoing, with potential future indications expanding its use.

4. What factors could accelerate safinamide’s market growth?
Increased prescriber awareness, expanding indications, geographic expansion into emerging markets, positive real-world evidence, and favorable reimbursement policies are key accelerators.

5. How does safinamide fit into the evolving Parkinson’s treatment paradigm?
Its dual-action profile complements existing therapies, addressing both motor and non-motor symptoms, positioning safinamide as a valuable component in personalized PD management strategies.

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References

[1] Dorsey, E.R., et al. (2018). "Global, regional, and national burden of Parkinson’s disease, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016." The Lancet Neurology, 17(11), 939–953.